human factors and medicine safety
TRANSCRIPT
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Human FactorsOptimising the usability of processes and technology in Pharma R&D
Andrew Alexander ParsonsMSc, PhDwww.reciprocalminds.com
5th Annual Pharmacovigilance Forum
2 March 2017Berlin
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A dilemmaAffordability vs Availability?
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Medicines Life Cycle – Traditional View
Discovery
Preclinical Phase 1 Phase 2 Phase 3 Phase 4
• Described as a linear process
• High attrition
• High costs in Operation
• Sales drive further innovation • (high cost due to attrition)
• Long cycle times - 10-20 years
• Many Risks and uncertainties
Favourable Scientific
and Regulatory Environme
nt
Cost effective use of
Medicine Societal
Value
Innovative New
DrugsR&D
Adequate cash Flow
Sales
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Changing Times and New Directions
• Stem cell therapies
• Gene therapies
• Epi-genetic modulation
• Focus on Orphan Disease• Limited Patient Numbers• Parallel development (e.g. cancer)
• Disaggregation of the industry• Small R&D companies supported by CRO and CMOs • Several Stakeholders in managing supply and operations
A linear model no longer describes the system!
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• Andrew A Parsons
• Allison Morgan
• Simon Whiteley
• Crystal Ruff
• Ralph Hibbard
Education and Training
Human Centred Organisations
• Brian Edwards
• Fiona Day
• Julia Mironova
Pharma HuF has several Teams
Systems Mapping Sub Team Pharma Huf
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Considerations
• Increasing usability and productivity
• Reducing errors
• Human Centred Organisations
• Safety
Human Factors – what are they?
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What are Human Factors?
• Capability depends on combination of interacting elements
• Operation of equipment and systems in circumstances of fatigue, hunger, stress and even fear
• Usability in demanding circumstances will determine success
• Named roles in Human Factor integration in product life cycle
Learning from Ministry of Defence UK
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Human Factors
• Is a risk management process – particularly around usability engineering
• Proactively manages all elements of the process• Application description• Requirements specifications• System design• Implementation
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The Process & Environment: Where conditions matter…
ChemistryReagent 1 + Reagent 2 Product 1 + Product 2
Innovation
People + Technology Product + Value
Catalyst
Process Conditions
Socio-Techno Process(e.g. Safety, Quality, Usability)
Investment
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Buying
Delivering
Doing
“What’s the benefit?”
“How will we provide that benefit?”
“What will we produce?”
3 Levels of Customer Value
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System Control Points
Quality
Safe and Effective Medicines
Organisation focus
Product or Medicine focus
ValueCost
Individual focus
Team focus
Safety
Buying
Delivering
Doing
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High Level System Control Points
Clinical Safety
Clinical Effective
ness
Management and Process
use-ability
Health and
Safety
Distribution
/ supply of Product
Manufacture
Product Use-
ability
Commercial Value
Payer Value
HCP Value
Product or Medicine focus
Individual focus
Patient Value
Societal Value
Management and Process Effectiveness
Compensation and reward
ProcessExtrinsic Motivatio
n
Intrinsic Motivatio
nAbilities
Autonomy
Political factors
Environmental
factors
Financial factors
Societal factors
Management and Process
use-ability
Health and
Safety
Team focus
Management and Process Effectiveness
Compensation and reward
Process
Political factors
Environmental factors
Financial factors
Societal factors
Perception
Bias / Heuristi
cs
Organisation focus
Safe and Effective Medicines
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Illustrative Example: Weighting of decisions in each phase
clinical safetyclinical effectivenesspayer valuemanufacture
product userbaiitycommercial value
patient value
HCP valuesocietal value
Distribution/Product supplyHealth and SafetyMangement and Process usebabilitypolitical factorsfinancial factorsmanagemnt and process effectiveness
compensation and reward processenvironmental factors
societal factors
intrinsic motivation
extrinsic motivationperception
abilitiesautonomybias/heuristics
0
5
preclinical
clinical safetyclinical effectivenesspayer valuemanufacture
product userbaiitycommercial value
patient value
HCP valuesocietal value
Distribution/Product supplyHealth and SafetyMangement and Process usebabilitypolitical factorsfinancial factorsmanagemnt and process effectiveness
compensation and reward processenvironmental factors
societal factors
intrinsic motivation
extrinsic motivationperception
abilitiesautonomybias/heuristics
0
2
4
phase 1
phase 1
clinical safetyclinical effectivenesspayer valuemanufacture
product userbaiitycommercial value
patient value
HCP valuesocietal value
Distribution/Product supplyHealth and SafetyMangement and Process usebabilitypolitical factorsfinancial factorsmanagemnt and process effectiveness
compensation and reward processenvironmental factors
societal factors
intrinsic motivation
extrinsic motivationperception
abilitiesautonomybias/heuristics
0
5
phase 2phase 2
clinical safetyclinical effectivenesspayer valuemanufacture
product userbaiitycommercial value
patient value
HCP valuesocietal value
Distribution/Product supplyHealth and SafetyMangement and Process usebabilitypolitical factorsfinancial factorsmanagemnt and process effectiveness
compensation and reward processenvironmental factors
societal factors
intrinsic motivation
extrinsic motivationperception
abilitiesautonomybias/heuristics
0
5
phase 3phase 3
clinical safetyclinical effectivenesspayer valuemanufacture
product userbaiitycommercial value
patient value
HCP valuesocietal value
Distribution/Product supplyHealth and SafetyMangement and Process usebabilitypolitical factorsfinancial factorsmanagemnt and process effectiveness
compensation and reward processenvironmental factors
societal factors
intrinsic motivation
extrinsic motivationperception
abilitiesautonomybias/heuristics
0
5
phase 4phase 4
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Steering CtteParty A Party B
Program TeamDevelopmen
t Project Team
Define and DecideWhere, What, HowWho DecidesTransparency of RisksCommunicateAlignment of Purpose Meaning rather than perceptions
Governance and Commissioning
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• Tracking lag measures – reactive and ‘out of control’. • Focus on the process (Lead) measures• Ensure Congruence of lag and lead measures
Performance Measures
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Use failure and effects analysis
• Lots of different risk management plans for when stuff does not work
• Focus of human safety analysis is SAFETY
• Process of assessment is
• 1 – task analysis
• 2 – PCA analysis (Perception, cognitive and action)
• 3- use error analysis
• Protocol evaluation
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Managing usability risks
• Task analysis - to each user error and how it is linked to PCA
Risk mitigation is
• Design – changes made to the design
• Protection – protective barrier put in place
• Information – changes to the instructions for use (training) – seen as weakest
HF focus: how to ensure the system can adapt to the human error
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Being Human Centred
Recognition that organisations have impact on customers and employees, their families and the wider community
It is an approach to integrate a social-technical methodologies and manage the complex risks of business today e.g.
• Wasted effort, poor efficiency, effectiveness and satisfaction
• Errors and system failures, product recalls…
• Absenteeism, presenteeism, poor recruitment and retention
• Litigation, reputational damage
• Etc….
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Putting Human Factors First – Principles
• Capitalise on individual differences as an organisational strength
• Make usability and accessibility strategic business objectives
• Adopt a total systems approach
• Ensure health, safety and wellbeing are business priorities
• Value employees and create meaningful work environments
• Be open and trustworthy and act in socially responsible ways
ISO 275000 Human Centred Organisations
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Can you help?
• Led by safety and HF Professionals Lee Allford and Shama Didla
• Aim to create “best practice” stories for the industry
• Can you share?
• Would you like to learn more?
Pharma Huf ISO27500 Workstream
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• Use design thinking
• Think systems and human factors
• Describe the solution state
• Remember you get what you measure• Lead and Lag measures• What we do• How we do it
Clear strategy, tactics and operations
How to change effectively
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In Life
Adaptability is Key
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Andrew A Parsons [email protected]+44 7854 029 268
Drag picture to placeholder or click icon to addThank You
Thanks to Colleagues in Pharmaceutical Human Factor SIG